The OHSU Pregnancy Exercise & Nutrition (PEN) Program (PEN)
Primary Purpose
Gestational Diabetes
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intervention, behavioral lifestyle education
Sponsored by
About this trial
This is an interventional prevention trial for Gestational Diabetes focused on measuring Gestational diabetes, Exercise, Diet, Fruits, Vegetables, Whole grains, pregnancy weight
Eligibility Criteria
Inclusion Criteria: Healthy first trimester pregnant women -
Exclusion Criteria: hypertension, diabetes, known cardiopulmonary disease; orthopedic problems or other conditions that would prevent regular physical activity.
-
Sites / Locations
- Oregon Health & Science University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention, behavioral lifestyle education
Control
Arm Description
Pregnant women will participate in 20 educational sessions designed to promote daily exercise, vegetable and fruit intake, maintain a diet that is relatively lower in fat and rich in whole grains.
Standard medical care
Outcomes
Primary Outcome Measures
Achieving 30 minutes of daily exercise, four or more times each week
Assessment of daily exercise (in minutes) during pregnancy and 12 weeks post pregnancy for the duration of the study.
Secondary Outcome Measures
Eating 5 or more servings of vegetables and/or fruits each day
Women will self-assess the number of servings of vegetables and fruits each day throughout the study.
Full Information
NCT ID
NCT01719406
First Posted
October 29, 2012
Last Updated
October 14, 2014
Sponsor
Oregon Health and Science University
1. Study Identification
Unique Protocol Identification Number
NCT01719406
Brief Title
The OHSU Pregnancy Exercise & Nutrition (PEN) Program
Acronym
PEN
Official Title
Randomized Control Pilot of a Behavior-based Exercise and Diet Intervention to Reduce Risk Factors for Gestational Diabetes Among Otherwise Healthy Pregnant Women.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Personal behaviors can influence development of Gestational Diabetes Mellitus (GDM), a condition that can adversely affect the pregnant woman, her developing fetus and future events for both. To reduce GDM risk, we will develop and implement an in-person team and web-based nutrition and exercise program for women, beginning in their first trimester. A scripted, peer-led, 20-week educational program, tailored for pregnant women working in teams (5 women/team), will be developed and implemented among pregnant employees and/or their spouses. Each weekly thirty minute session will focus on achieving 30-minutes of moderate daily physical activity with nutrition targets of five servings of fruits and vegetables, 3 servings of whole grains and lower fat food choices. Diet, exercise and lab assessments will occur before enrollment during the first trimester, each subsequent trimester and 12 weeks after delivery. In addition to exercise and diet survey results, we will assess fasting glucose, insulin, hemoglobin A1C levels, pregnancy weight gain, blood pressure, lipid and lipoprotein levels, pedometer records, weekly accelerometer data, each trimester and at 12 weeks post delivery, as well as gestational birth age, Apgar score, delivery mode and infant birth weight, and weekly health thermometer self-ratings during the assessment period.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes
Keywords
Gestational diabetes, Exercise, Diet, Fruits, Vegetables, Whole grains, pregnancy weight
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention, behavioral lifestyle education
Arm Type
Experimental
Arm Description
Pregnant women will participate in 20 educational sessions designed to promote daily exercise, vegetable and fruit intake, maintain a diet that is relatively lower in fat and rich in whole grains.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Standard medical care
Intervention Type
Behavioral
Intervention Name(s)
Intervention, behavioral lifestyle education
Other Intervention Name(s)
Lifestyle, Nutrition, Exercise, Stress management
Intervention Description
Twenty interactive weekly sessions that are scripted curriculum and peer led.
Primary Outcome Measure Information:
Title
Achieving 30 minutes of daily exercise, four or more times each week
Description
Assessment of daily exercise (in minutes) during pregnancy and 12 weeks post pregnancy for the duration of the study.
Time Frame
32 weeks
Secondary Outcome Measure Information:
Title
Eating 5 or more servings of vegetables and/or fruits each day
Description
Women will self-assess the number of servings of vegetables and fruits each day throughout the study.
Time Frame
32 weeks of the study
Other Pre-specified Outcome Measures:
Title
Pregnancy weight gain
Description
Assess pregnancy weight gain, in which excessive weight gain is a risk factor for gestational diabetes.
Time Frame
20 weeks
Title
HemoglobinA1C
Description
Assessing the average plasma glucose concentration over longer time periods.
Time Frame
Each trimester and 12-weeks post delivery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy first trimester pregnant women -
Exclusion Criteria: hypertension, diabetes, known cardiopulmonary disease; orthopedic problems or other conditions that would prevent regular physical activity.
-
Facility Information:
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
12. IPD Sharing Statement
Learn more about this trial
The OHSU Pregnancy Exercise & Nutrition (PEN) Program
We'll reach out to this number within 24 hrs